title: A national quality assurance survey of Neisseria gonorrhoeae testing.
abstract: The aims of this study were to (1) conduct a national survey of Neisseria gonorrhoeae identification by National Neisseria Network (NNN) reference laboratories contributing data to the Australian Gonococcal Surveillance Programme and (2) determine the prevalence in Australia of strains of N. gonorrhoeae lacking gene sequences commonly targeted by in-house PCR assays for confirmation of gonococcal nucleic acid amplification tests. Gonococcal clinical isolates referred to NNN laboratories for the first half of 2012 were screened using in-house real-time PCR assays targeting multicopy opa, porA pseudogene and cppB genes. There were 2455 clinical gonococcal isolates received in the study period; 98.6 % (2420/2455) of isolates harboured all three gene targets, 0.12 % (3/2455) were porA-negative, 0.04 % (1/2455) opa-negative and 1.14 % (28/2455) cppB-negative by PCR. Notably, no isolates were simultaneously negative for two targets. However, three isolates failed to be amplified by all three PCR methods, one isolate of which was shown to be a commensal Neisseria strain by 16S rRNA sequencing. Using PCR as the reference standard the results showed that (1) identification of N. gonorrhoeae isolates by NNN laboratories was highly specific (99.96 %) and (2) strains of N. gonorrhoeae lacking gene sequences commonly targeted by in-house PCR assays are present but not widespread throughout Australia at this point in time.
authors.affiliation: Queensland Children's Medical Research Institute, University of Queensland, Queensland, Australia.|Queensland Paediatric Infectious Diseases Laboratory, Queensland Children's Health Services, Queensland, Australia.
authors.forename: Ella
authors.initials: E
authors.lastname: Trembizki
authors.affiliation: WHO Collaborating Centre for STD, Microbiology Department, South Eastern Area Laboratory Services, Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors.forename: Monica
authors.initials: M
authors.lastname: Lahra
authors.affiliation: Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Kerrie
authors.initials: K
authors.lastname: Stevens
authors.affiliation: Microbiology Laboratory, Pathology Department, Royal Darwin Hospital, Darwin, Northern Territory, Australia.
authors.forename: Kevin
authors.initials: K
authors.lastname: Freeman
authors.affiliation: WHO Collaborating Centre for STD, Microbiology Department, South Eastern Area Laboratory Services, Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors.forename: Tiffany
authors.initials: T
authors.lastname: Hogan
authors.affiliation: Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Geoff
authors.initials: G
authors.lastname: Hogg
authors.affiliation: Microbiology and Infectious Diseases Department, Women's and Children's Hospital, North Adelaide, South Australia, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Lawrence
authors.affiliation: WHO Collaborating Centre for STD, Microbiology Department, South Eastern Area Laboratory Services, Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors.forename: Athena
authors.initials: A
authors.lastname: Limnios
authors.affiliation: PathWest Laboratory Medicine-WA, Royal Perth Hospital, Perth, Western Australia, Australia.
authors.forename: Julie
authors.initials: J
authors.lastname: Pearson
authors.affiliation: Public Health Microbiology, Communicable Disease, Queensland Health Forensic and Scientific Services, Archerfield, Queensland, Australia.
authors.forename: Helen
authors.initials: H
authors.lastname: Smith
authors.affiliation: Microbiology Division, Pathology Queensland Central, Royal Brisbane and Women's Hospital Campus, Queensland, Australia.|Queensland Children's Medical Research Institute, University of Queensland, Queensland, Australia.|Queensland Paediatric Infectious Diseases Laboratory, Queensland Children's Health Services, Queensland, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Nissen
authors.affiliation: Microbiology Division, Pathology Queensland Central, Royal Brisbane and Women's Hospital Campus, Queensland, Australia.|Queensland Children's Medical Research Institute, University of Queensland, Queensland, Australia.|Queensland Paediatric Infectious Diseases Laboratory, Queensland Children's Health Services, Queensland, Australia.
authors.forename: Theo
authors.initials: T
authors.lastname: Sloots
authors.affiliation: Queensland Children's Medical Research Institute, University of Queensland, Queensland, Australia.|Queensland Paediatric Infectious Diseases Laboratory, Queensland Children's Health Services, Queensland, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Whiley
authors.lastname: On Behalf Of 'grand' Study Investigators
mesh_terms: D001315:Australia; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D059021:Laboratory Proficiency Testing; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D011785:Quality Assurance, Health Care; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity